Intact Pharmaceuticals LLC
Form 483 issued October 12, 2018 · New Milford, Connecticut
- Inspection
- Sep 10 – Oct 12, 2018
- Investigators
- Djamila Harouaka· Edmund F. Mrak
- Observations
- 11
- Pages
- 15
- FEI number
- 3014184709
In short: On October 12, 2018, FDA issued a Form 483 with 11 observations to Intact Pharmaceuticals LLC in New Milford, Connecticut (FEI 3014184709) after an inspection that ran Sep 10 – Oct 12, 2018. The investigators were Djamila Harouaka and Edmund F. Mrak. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 8 of 11 observations.
Most cited: 21 CFR 211.42 (3×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
EMPI.OVEE(S) SIGNATIJRE OATEISSUEO Procedures designed to prevent microbiological contamination of drug products purporting to be sterile…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmIntact Pharmaceuticals LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intact Pharmaceuticals LLC?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Intact Pharmaceuticals LLC?
Djamila Harouaka and Edmund F. Mrak are named on this Form 483, for the inspection of Sep 10 – Oct 12, 2018. Each investigator has a profile showing what they cite most.
When was Intact Pharmaceuticals LLC inspected by FDA?
The inspection ran Sep 10 – Oct 12, 2018, and the Form 483 is dated October 12, 2018.
How do I get the full Form 483 for Intact Pharmaceuticals LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.